- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01941498
WaveLight® Refractive Myopic Study
October 2, 2015 updated by: Alcon Research
A Prospective, Global, Multi-Center Study for the Evaluation of Outcomes on Subjects Undergoing Myopic Treatments Using the WaveLight® Refractive Suite
The purpose of this study is to evaluate outcomes of subjects undergoing myopic surgery using the WaveLight® Refractive Suite (Excimer EX500 and Femtosecond FS200 lasers).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Willing and able to understand and sign an informed consent form.
- Have refractive error (in both eyes) that requires refractive surgery.
- Willing to undergo LASIK surgery using the Wavelight® Refractive Suite.
- Myopia between 0.00 to -12.0 diopters pre-operatively.
- Astigmatism between 0.00 to +6.00 diopters pre-operatively.
- Willing and able to attend post-operative examinations per protocol schedule.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Participation in a clinical study within the last 30 days.
- History of previous corneal surgery in either eye.
- Multifocal ablations in either eye.
- PRK or PTK surgery in either eye.
- Suffering from acute or recurring eye diseases in either eye, such as corneal ulcers, cataract, etc.
- Any ocular disease and/or condition that, in the Investigator's clinical judgment, may put subject at significant risk, compromise study results, or interfere significantly with subject's participation in the study.
- Unable to discontinue contact lens wear as specified in protocol.
- History of Herpes simplex or Herpes zoster keratitis.
- Active ocular rosacea.
- Lyme disease.
- History of dry eye that is unresponsive to treatment.
- Severe ocular allergies.
- Other medical conditions and use of medications as specified in protocol.
- Pregnant or planning to become pregnant during the study.
- Other protocol-specified exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WaveLight Refractive Suite
LASIK surgery (laser in situ keratomileusis) per standard of care
|
Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation
Surgical procedure for treating refractive error based on corneal reshaping
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA
Time Frame: Month 1
|
Visual acuity (VA) with corrective devices (BCVA) was assessed binocularly (both eyes together) pre-treatment and subtracted from VA without spectacles or other visual corrective devices (UCVA) assessed binocularly at 1 month post-treatment.
VA was measured at a distance of 4 meters and reported in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen.
A negative value indicates an improvement in VA from pre-treatment to Month 1.
|
Month 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT
Time Frame: Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative
|
The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness as assessed by optical coherence tomography (OCT) (ie, an imaging method using light to capture three-dimensional images).
A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number.
|
Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative
|
Mean Manifest Refraction (Sphere)
Time Frame: Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
|
Manifest refraction was performed under photopic lighting conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters.
The subject was manually refracted to his/her best correction using a phoropter.
Each eye individually contributed to the mean.
|
Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
|
Mean Manifest Refraction (Cylinder)
Time Frame: Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
|
Manifest refraction was performed under photopic lighting conditions using an ETDRS chart at 4 meters.
The subject was manually refracted to his/her best correction using a phoropter.
Each eye individually contributed to the mean.
|
Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
|
Mean Laser Treatment Time
Time Frame: Day 0 (surgery)
|
Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds.
|
Day 0 (surgery)
|
Mean Total Laser Treatment Time
Time Frame: Day 0 (surgery)
|
Total treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds.
Total duration for both eyes was calculated as sum of duration for the right eye and left eye.
|
Day 0 (surgery)
|
Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"
Time Frame: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
|
As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error, on a scale from 0 (completely blind) to 10 (perfect vision).
|
Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
|
Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..."
Time Frame: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
|
As recorded by the subject on the RSVP questionnaire, where n/a means no use of glasses or contact lenses.
|
Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
|
Percent Response by Category: "I Worry About my Vision"
Time Frame: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
|
As recorded by the subject on the RSVP questionnaire
|
Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
|
Percent Response by Category: "My Vision Is a Concern in My Daily Life"
Time Frame: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
|
As recorded by the subject on the RSVP questionnaire
|
Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
|
Percent Response by Category: "Driving at Night"
Time Frame: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
|
As recorded by the subject on the RSVP questionnaire, where 0 is "Not applicable", 1 is "No difficulty at all", 2 is "A little difficulty", 3 is "Moderate difficulty", 4 is "Severe difficulty" and 5 is "So much difficulty that I did not do the activity with this alternative".
|
Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
|
Mean Contrast Sensitivity (CS)
Time Frame: Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
|
Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected.
Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd), where 3.0 cpd = A, 6.0 cpd = B, 12.0 cpd = C, and 18.0 cpd = D. Raw scores were log transformed.
A higher numeric value represents better contrast sensitivity.
|
Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
|
Wavefront Aberrometry
Time Frame: Baseline (Day 0), Month 6 Postoperative
|
Wavefront aberrations (optical imperfections of the eye that prevent light from focusing perfectly on the retina, resulting in defects in the visual image) were measured using a commercially available system.
Higher order aberrations (i.e., spherical aberrations, coma, and trifoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology.
|
Baseline (Day 0), Month 6 Postoperative
|
Corneal Curvature as Measured by Keratometry
Time Frame: Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
|
Corneal curvature was assessed by a commercially available system and measured in diopters.
|
Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Manager, GMA, Surgical, Alcon Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
September 10, 2013
First Submitted That Met QC Criteria
September 10, 2013
First Posted (Estimate)
September 13, 2013
Study Record Updates
Last Update Posted (Estimate)
November 3, 2015
Last Update Submitted That Met QC Criteria
October 2, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A01353
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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